Buffalo Neuroimaging Analysis Center, Department of Neurology, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York , Buffalo, NY, USA.
Jacobs Comprehensive MS Treatment and Research Center, Department of Neurology, Jacobs School of Medicine and Biomedical Sciences University at Buffalo , Buffalo, NY, USA.
Expert Opin Drug Saf. 2020 Sep;19(9):1121-1142. doi: 10.1080/14740338.2020.1805430. Epub 2020 Aug 13.
The portfolio of multiple sclerosis (MS) disease modifying treatments (DMTs) has significantly expanded over the past two decades. Given the lifelong use of MS pharmacotherapy, understanding their long-term safety profiles is essential in determining suitable and personalized treatment.
In this narrative review, we summarize the short-, mid-, and long-term safety profile of currently available MS DMTs categories. In addition to the initial trial findings, safety outcomes derived from long-term extension studies (≥5-20 years) and safety-based prescription programs have been reviewed. In order to better understand the risk-benefit ratio for each particular DMT group, a short description of the DMT-based efficacy outcomes has been included.
Long-term extension trials, large observational studies and real-world databases allow detection of rare and potentially serious adverse events. Two-year-long trials are unable to fully capture the positive and negative effects of immune system modulation and reconstitution. DMT-based monitoring programs can provide greater insights regarding safe use of MS medications in different patient populations and clinical settings. During the process of shared DMT decision, both MS care providers and their patients should be aware of an ever-expanding number of drug-based adverse events and their influence on the risk-benefit analysis.
多发性硬化症（MS）疾病修正治疗（DMT）的组合在过去二十年中显著扩大。鉴于 MS 药物治疗需要终身使用，了解其长期安全性对于确定合适和个性化的治疗方案至关重要。
在这篇叙述性综述中，我们总结了目前可用的 MS DMT 类别在短期、中期和长期的安全性概况。除了最初的试验结果外，还审查了来自长期扩展研究（≥5-20 年）和基于安全性的处方计划的安全性结果。为了更好地了解每个特定 DMT 组的风险效益比，还包括了基于 DMT 的疗效结果的简短描述。
长期扩展试验、大型观察性研究和真实世界数据库可以检测罕见且潜在严重的不良事件。为期两年的试验无法完全捕捉免疫系统调节和重建的积极和消极影响。基于 DMT 的监测计划可以为不同患者人群和临床环境中 MS 药物的安全使用提供更深入的了解。在共同制定 DMT 决策的过程中，MS 护理提供者及其患者都应该意识到不断增加的药物相关不良事件及其对风险效益分析的影响。
